Status:
WITHDRAWN
Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection
Lead Sponsor:
Guerbet
Conditions:
Nephrogenic Systemic Fibrosis
Renal Insufficiency
Eligibility:
All Genders
Brief Summary
The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate rena...
Eligibility Criteria
Inclusion
- Referred for contrast-enhanced MRI using gadoversetamide;
- Have a documented estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2 within the past 6 months or ESRD requiring dialysis; and
- Willing and able to provide written consent (themselves or by a legally authorized representative) and agree to abide by study requirements, including being seen by a dermatologist and undergoing a skin biopsy if NSF is suspected.
Exclusion
- Have experienced a previous hypersensitivity reaction to a GBCA;
- Have pre-existing NSF or NSF-like symptoms; or
- Have been exposed to a GBCA within 12 months prior to the index procedure; or
- Has a medical condition or other personal situation that would prevent providing follow-up information, completing clinic visits or otherwise supplying meaningful data to meet study objectives.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 17 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00811863
Start Date
February 1 2009
End Date
May 17 2012
Last Update
August 2 2017
Active Locations (1)
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1
Radiology Consultants, Inc.
Youngstown, Ohio, United States, 44512